Bladder Fiducial Markers and Multiparametric-MRI (mp-MRI) to Optimize Bladder Chemo-radiotherapy

Description

The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.

Conditions

Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases

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Study Overview

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Study Details

Study overview

The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.

Bladder Fiducial Markers and Multiparametric-MRI (mp-MRI) to Optimize Bladder Chemo-radiotherapy

Bladder Fiducial Markers and Multiparametric-MRI (mp-MRI) to Optimize Bladder Chemo-radiotherapy

Condition
Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center (CSMC), Los Angeles, California, United States, 90048

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095

Boston

Harvard School of Medicine/Massachusetts General Hospital (MGH), Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.
  • * Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder
  • * Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation
  • * Adequate renal function: Serum creatinine \< 2 mg/dL OR calculated creatinine clearance (CrCl) \> 30ml/min
  • * Ability to understand and willingness to sign a written informed consent
  • * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation
  • * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • * Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed
  • * Known distant metastatic disease (e.g. pulmonary or hepatic metastases)
  • * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed
  • * Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)
  • * Planned (or prior history of) definitive bladder irradiation
  • * Intravesical chemo- or biologic therapy within 6 weeks of first treatment
  • * Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion
  • * Clinically significant active infection or uncontrolled medical condition that would preclude participation in study
  • * Pregnant or nursing women are excluded
  • * Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment
  • * Individuals with severe renal failure and cannot receive MRI contrast

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

Maurice Garcia, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2025-04